Sunday, November 07, 2010

"Firsts" of the Day for the FDA

The Food and Drug Administration said ... that it would rescind the approval of a patch for injured knees that it granted in error in 2008 after being unduly pressured by four New Jersey congressmen and its own commissioner. The patch, known as Menaflex and manufactured by ReGen Biologics, was so different from earlier devices that it should have been tested far more thoroughly before approval, officials determined. . . .

The F.D.A. had never before admitted that it approved a drug or device mistakenly, never rescinded such an approval without citing new information about the product, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.

Certain Democratic Congressmen appear to have acted on behalf of their generous comporate constituent—

The controversy surrounding Menaflex began last year, when a group of F.D.A. medical officers complained to Senator Charles E. Grassley, Republican of Iowa, that the ReGen decision was one of several at the agency in which politics inappropriately trumped science.

The agency responded by releasing a detailed report last year that found that the agency’s scientific reviewers had repeatedly and unanimously over many years declared Menaflex unworthy of approval, but that they had been overruled by agency managers after political pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman. The report also concluded that Dr. Andrew C. von Eschenbach, then the agency’s commissioner, had become inappropriately involved in the decision, and that agency procedures had been bypassed.

All four lawmakers made their inquiries about Menaflex after receiving significant campaign contributions from ReGen, which is based in Hackensack, N.J. Dr. von Eschenbach and the four lawmakers said they acted properly.